Status:
COMPLETED
Influence of Cataract Surgery on Early DME The DICAT-II Study
Lead Sponsor:
European School of Advanced Studies in Ophthalmology
Conditions:
Diabetic Macular Edema
Cataract Senile
Eligibility:
All Genders
55-80 years
Brief Summary
To determine if cataract surgery may have an impact on the natural history of early DME (E-DME)
Detailed Description
Cataract surgery worsens preoperative DME, deserving an adequate pre and postoperative treatment. A large British study demonstrated that even eyes without preexisting edema are at risk of DME develop...
Eligibility Criteria
Inclusion
- Eligible patients will be identified during the regular preoperative cataract examination. In the presence of a diabetic patient, an OCT scan will be performed (according to the protocol, see below).
- Only eyes with E-DME will be eligible for the study.
- Inclusion criteria may be one of the following:
- Diabetic patients with bilateral E-DME and bilateral cataract. Both eyes will be enrolled: one eye will receive surgery at M4, the other at the end of follow up (M8) or later (gold candidate).
- Diabetic patients with bilateral E-DME and cataract in just one eye (gold candidate). The eye with E-DME and no cataract may be already pseudophakic (surgery performed at least 18 months before) or with clear media.
- Diabetic patients with E-DME and cataract in just one eye
- Diabetic patients with cataract and no E-DME in the eye scheduled for surgery but E-DME in the other eye. Only the eye with E-DME will be enrolled.
Exclusion
- Past ocular surgery of any kind (except for cataract surgery) or ocular pathologies other than diabetic retinopathy.
- Macular edema considered to be due to a cause other than diabetic macular edema.
- OCT examination suggesting that vitreoretinal interface abnormalities (e.g., a taut posterior hyaloid or epiretinal membrane) are the primary cause of the macular edema. In the case of ERM, an OCT scan must be sent to the Coordinating Center for approval.
- Any ocular pathology or ocular condition is present (other than diabetes) that, in the opinion of the investigator, might affect macular edema
- History of any therapy (anti-VEGF treatment, focal/grid macular photocoagulation, intravitreous or peribulbar corticosteroids) for DME or diabetic retinopathy in the past 12 months.
- History of YAG capsulotomy performed within two months before enrollment.
- Aphakia.
- Evidence of uncontrolled glaucoma.
- Intraocular pressure must be \<25 mmHg, with no more than one topical glaucoma medication.
Key Trial Info
Start Date :
January 28 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 31 2021
Estimated Enrollment :
143 Patients enrolled
Trial Details
Trial ID
NCT04096131
Start Date
January 28 2020
End Date
January 31 2021
Last Update
August 16 2021
Active Locations (1)
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1
ESASO Scientific Projects
Lugano, Switzerland, CH-6901